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NCT ID: NCT06055075 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma

Start date: December 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of forimtamig when administered alone or in combination with carfilzomib or daratumumab or other combination partners in participants with relapsed or refractory multiple myeloma (r/r MM). The study consists of two phases: a dose exploration phase and a dose-expansion phase.

NCT ID: NCT06054555 Recruiting - Melanoma Clinical Trials

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

NCT ID: NCT06054477 Recruiting - Clinical trials for Head and Neck Cancer

Study of ALE.C04 in Patients With Head and Neck Cancer

Start date: October 30, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.

NCT ID: NCT06054074 Completed - Low Back Pain Clinical Trials

Virtual Reality-based Induction to Improve Positive Body Image in Low Back Pain Patients.

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to examine the effects of a Virtual Reality-based induction to modify positive body image in individuals with low back pain. Participants will receive both a positive and a negative induction of the appreciation of body functionality. This induction consists of an elaborated narrative to increase/decrease the appreciation of functionality. In addition, each induction includes a virtual costume representing their body's strengths or weaknesses to enrich the induction. After both induction procedures, participants will perform activities of daily living involving the use of the lumbar region in virtual reality. Subsequently, the different variables of interest will be assessed before and after each induction. Researchers will analyze changes in the variables of interest after induction procedures compared to baseline.

NCT ID: NCT06054061 Recruiting - Mental Disorder Clinical Trials

Evaluation the Efficacy "Think and Cope Positively" Program

PA+
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether an integrated protocol based on cognitive behavioural therapy, positive psychology and third generation therapies is effective in improve the subjective well-being of people affected by a severe mental illness (SMI). The design of the study is a cluster randomized control trial with two arms. Experimental groups will receive 15 sessions to enhance positive emotions, optimism, adaptive coping, finding a purpose in life and sharing it with people who are important to the user. The control group will remain on a waitlist with their treatment as usual (TAU). After the control period (15 weeks), participants of the experimental groups have the chance to receive the intervention. Both groups will be measure before and after de 15 intervention weeks. Additionally, follow-up measures of the experimental group will be taken after 3 and 6 months.

NCT ID: NCT06053775 Recruiting - Clinical trials for Cognitive Impairment

Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)

ONCODEP
Start date: September 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a home-delivered intervention that combines Non-Invasive Brain Stimulation techniques (transcranial direct and alternating current stimulation -tDCS and tACS-) and Online Cognitive Training (OCT) to treat depressive symptomatology and cognitive decline associated with breast cancer. The main questions aims to be answered are: - To analyze the efficacy and feasibility of the intervention to treat depressive symptomatology. - To analyze the efficacy and feasibility of the intervention to treat cognitive decline. - To evaluate the medium and long-term effects (1, 3 and 6 months) of intervention. An OCT program and a portable wireless tDCS/tACS system will be used to perform the intervention at home. Patients will be divided into four treatment groups, depending on whether they will receive the OCT applied independently or combined with tDCS/tACS active or sham. In addition, saliva samples will be collected to identify bomarkers predictive of treatment efficacy.

NCT ID: NCT06053073 Recruiting - Induced; Birth Clinical Trials

Induction to Labour With Double Cervical Ballon at Home Versus at Hospital

INDOBAMHOS
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial] is to compare the outcomes between induction to labour at home versus hospitalized. The main questions it aims to answer are: - Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate? - Will the induction to labour at home increase maternal satisfaction - Will the induction to labour at home improve medical circuits and coulb it be cost effective? Participants who meet inclusion criteria will undergo randomization so as to be asignated an induction to labour at home or in the hospital. Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.

NCT ID: NCT06052436 Recruiting - Clinical trials for Systemic Inflammatory Response Syndrome

Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)

THYTECH2
Start date: June 27, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I/II clinical trial to evaluate the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children (NCT04924491), with preliminary results indicating the feasibility and safety of the therapy. In addition, thyTreg cells have shown low immunogenicity in the pre-clinical setting, indicating that allogeneic use of these thyTreg cells (allo-thyTreg) would have a low risk of adverse effects. These thyTreg cells could inhibit an excessive inflammation in SARS-CoV-2 infection, or ameliorate the immunological affection underlying Acute respiratory distress syndrome, improving life-threatening manifestations, restoring immune balance, and protecting affected tissues. This clinical trial is an open-label Sequential Parallel Group Phase I/II study to evaluate the safety and efficacy of allogeneic thymus derived Tregs (thyTreg) (thyTreg) in controlling the immune dysregulation associated with SARS-CoV-2 infection and/or Acute Respiratory Distress Syndrome.

NCT ID: NCT06051799 Recruiting - Clinical trials for Trigger Point Pain, Myofascial

Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The study aims to compare the effectiveness of myofascial trigger point treatment using pressure release versus a control group in patients with mechanical neck pain, randomly assigned. In both groups a protocol of therapeutic exercise and postural correction will be carried out

NCT ID: NCT06051461 Not yet recruiting - Obesity Clinical Trials

Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular Communication

DIETEVOME
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and coronary vascular disease. Excessive comsumption of fats enriched in saturated fatty acids (SFAs) is associated with an increased risk of atherosclerosis and other cardiovascular diseases (CVD). In contrasts, replacement of SFAs with monounsaturated fatty acids (MUFAs) and omega-3 long chain polyunsaturated fatty acids (ω3-LCPUFAs) has been reported to be inversely associated with risk of atherosclerosis. This is partly due to the ability of MUFAs (and ω3-LCPUFAs) to modulate lipoprotein composition, oxidation state, and consequently their functionality, among others. While most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect lipoprotein particles, little or nothing is known about the regulatory effect of dietary fatty acids on extracellular vesicles (EVs). EVs are small phospholipid particles that convey molecular bioactive cargoes and play essential roles in intercellular communication and, hence, a multifaceted role in health and disease. For the first time, the purpose of this project is to establish whether the type of major fatty acids present on a diet (SFAs, MUFAs, or ω3-LCPUFAs) may alter the structure, cargo, and functionality of postprandial- and long-term-EVs. In the precision nutrition era, the investigators expect to offer a new insight on EVs and their relationship with dietary fatty acids through the following objectives: 1) To map changes in the lipidome, proteome, microtranscriptome, and functional properties of circulating EVs in healthy subjects and patients with metabolic syndrome (MetS) both at fasting and at postprandial state upon a challenge of a meal rich in SFAs, MUFAs, and ω3-LCPUFAs; 2) To analyse the contribution of postprandial triacylglyceride-rich lipoproteins (TRL) on EVs-mediated intercellular communication in a fatty acid-dependent manner; and 3) To determine the influence of diets rich in SFAs, MUFAs, and ω3-LCPUFAs on EVs in an animal model of atherosclerosis in the setting of MetS. Collectively, this project will provide fundamental insight into EV biology, and remarks the clinical and functional relevance and divergent consequences of dietary fatty acids in health and disease.